Equipment Qualification and Validation of Processes

Location: Raleigh-Durham, NC, USA       Duration: 2 days

Date: September 13 - 14, 2018 from 830AM-430PM edt

Presenter: Joy McElroy

The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls — you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.

Areas Covered:

• Regulatory Requirements and Expectations for Equipment Qualification

  • Europe

  • FDA

    • Global harmonization and expectations

    • Management of Documents, Documents Required

  • Validation policy

    • Validation Master Plan (VMP)

    • Documents equipment qualification

    • SOPs

    • Responsibilities

    • Validation team

  • Presumption for qualification/validation

• General Aspects of Qualification

  • Qualification phases, DQ, IQ, OQ, PQ

  • Qualification of existing systems and equipment

  • Requalification/validation

• Performance Qualification and Process Validation

  • SOPs

  • Writing a qualification protocol, content

  • Executing a qualification

  • Tests and data

  • Documents

  • Writing a qualification final report